The Board of Directors and the Chief Executive Officer of Alzinova AB hereby present the interim report for the period January – September 2026. The full report, which is attached in the press release, can also be downloaded from the company’s English website, www.alzinova.com/investors/financial-reports/.
Three months, July–September 2026
Nine months, January–September 2026
Amounts in brackets: Corresponding period in previous year.
*After the end of the period, the company’s liquidity has been strengthened through the receipt of approximately SEK 38 million in proceeds from a share issue in mid-November.
Significant events during the third quarter 2026
Significant events after the third quarter 2026
A word from CEO Tord Labuda
Dear Shareholders,
During the third quarter, we advanced ALZ-101 from preparations for Phase II to the operational start-up of our global Phase IIa study, ADVANCE. Following the end of the quarter, we also completed the selection of seven clinical trial sites in the important US market and carried out a rights issue that provides Alzinova with approximately SEK 44 million before issue costs. Together, these steps put us in a position to advance the program towards patient recruitment.
For me, it is important to explain both what this progress means and what remains to be done. We have a completed Phase Ib study to build on and a clearly defined study for the next stage of development. Our focus is now on putting the clinical, regulatory and manufacturing-related elements in place so that we can begin to answer the most important question: can the immune response generated by ALZ-101 translate into a clinically meaningful effect in patients with early Alzheimer’s disease?
ALZ-101 – from immune response to evaluation of clinical efficacy
Our Phase Ib study demonstrated a favorable safety and tolerability profile, as well as a robust and long-lasting immune response. A total of 31 out of 32 patients demonstrated the desired immune response. This is an important result for a therapeutic vaccine and, together with the exploratory observations, supports further development.
With ADVANCE, we will take the next step and evaluate the treatment effect more systematically. The study is planned to include approximately 120 participants with early Alzheimer’s disease and is randomized, double-blind and placebo-controlled. The primary efficacy endpoint is the change in cognitive function after 52 weeks of treatment, measured using ADCOMS. Participants will be followed for a total of 92 weeks, allowing us to monitor disease progression over a longer period. In addition, the study will provide further insights into safety, tolerability and disease-related biomarkers. This is where I see the core of our continued value creation.
Our focus is to give ALZ-101 the best possible conditions to demonstrate its clinical potential. This requires a well-executed clinical development program, disciplined capital allocation and clear monitoring of the milestones that will move us forward.
Together with Worldwide Clinical Trials, we are preparing the clinical trial sites for recruitment. The selection of the seven US sites has been completed, and our objective is to enroll the first participant around the turn of 2026/2027. Before then, several steps remain, including approval of the final protocol amendment and release of the clinical trial material following completed quality controls. These activities, together with the readiness of the trial sites, are now the main focus of the clinical start-up process. In parallel, we are preparing the European clinical trial application, which we plan to submit via CTIS in November, representing the next regulatory step towards conducting the study in the EU.
Capital to advance the study
The rights issue completed in October was subscribed to approximately 86.2 percent and provides us with approximately SEK 44 million before issue costs, without the need to utilize the guarantee commitments. I would like to thank both existing and new shareholders for their confidence. Our responsibility is to use this capital with clear priorities and to monitor what it achieves.
Approximately 80 percent of the net proceeds are intended for the Phase II study and related CMC activities, including manufacturing, process development and quality control. The remaining proceeds are intended for working capital. Furthermore, the fact that most of the guarantee compensation is paid in units rather than cash means that more liquidity remains within the company. The issued warrants of series TO5 and TO6 are an integral part of our financing plan and may provide additional capital upon exercise, while we continue to work towards establishing the long-term financial conditions necessary to carry out the Phase II study.
Partnership activities supported by a clearer clinical position
With ADVANCE now in the operational start-up phase, we have a more concrete basis for deepening discussions with potential pharmaceutical partners regarding the execution of the study and the continued development of ALZ-101.
During November, our focus is on CTAD, BIO-Europe and Jefferies. In parallel, we are preparing for J.P. Morgan Week in January. Our objective is to advance these discussions based on the program’s next steps. The presentation of ADVANCE at CTAD also provides an opportunity to discuss the study design with an international clinical and scientific audience.
Our efforts to establish a potential collaboration in Saudi Arabia have provided us with valuable contacts with several relevant stakeholders. We continue to see opportunities for collaboration in the longer term, although the current geopolitical situation in the region is limiting our ability to advance these discussions. We are therefore keeping the door open while prioritizing other avenues in our near-term planning.
Diagnostics – a separate commercial opportunity
In September, we completed the study conducted in collaboration with Amsterdam UMC. The results are consistent with our previous observations and support the continued development of a blood-based test that measures naturally occurring antibodies against toxic amyloid-beta oligomers. The next development steps include optimization of the analytical method and evaluation in a larger, independent clinical cohort.
For us, diagnostics represents a new opportunity to create value from our patented technology through an application other than treatment. Building on the letter of intent, we are continuing our dialogue with Fujirebio regarding a potential development and commercialization partnership. We are optimistic about the opportunity to translate the scientific evidence and industrial interest into a collaboration and licensing agreement.
The diagnostics program is conducted independently of ALZ‑101 and has a potentially shorter development path than traditional drug development.
Clear priorities for the next steps
Over the coming period, shareholders will be able to follow three concrete areas of progress: regulatory developments in the US and EU, completion and release of the clinical trial material, and the transition of clinical trial sites to patient recruitment. Together, these steps will determine when ADVANCE can begin enrolling participants.
My responsibility is to coordinate these efforts and ensure that resources are allocated where they can deliver the greatest value. We will communicate what has been accomplished, what remains to be done and how this affects the path forward. This is how we intend to honor your trust and build long-term value for patients and shareholders.
Thank you for your continued support.
For further information, please contact:
Tord Labuda, CEO
E-mail: info@alzinova.com
About Alzinova AB
Alzinova AB is a Swedish biopharmaceutical company in clinical development specializing in the treatment of Alzheimer's disease, where the starting point is to attack toxic amyloid-beta oligomers. The lead candidate ALZ-101 is a therapeutic vaccine against Alzheimer's disease. Alzinova's patented AβCC peptide technology makes it possible to develop disease-modifying treatments that target the toxic amyloid-beta oligomers that are central to the onset and development of the disease with great accuracy. From a global perspective, Alzheimer's disease is one of the most common and devastating neurological diseases, with around 40 million affected today. Based on the same technology, the company is also developing the antibody ALZ-201, which is currently in preclinical development, and the goal is to further expand the pipeline. The company's Certified Adviser on Nasdaq First North Growth Market is Mangold Fondkommission AB. For more information about Alzinova, please visit: www.alzinova.com